An observational study in Neuromuscular Diseases, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. It will also aim to evaluate the intra-subject repeatability of measures for patients who receive more than one MIE cycle as part of their usual care. It will be the first to measure MIE assisted PCF contemporaneously during intervention using the gold standard pneumotachograph. This will inform treatment effect size and the efficacy of usual practice MIE in augmenting PCF measurements above critical cut off values for effective cough and secretion clearance.
Finally the study will also aim to understand how patients perceive the impact of MIE in clearing secretions from their chest by asking them to rate presence of chest secretions pre and post intervention using a visual analogue scale (VAS)
Patients with a neuromuscular disease (NMD) lose strength in their breathing muscles which leads to an inability to generate an effective cough. Peak Cough Flow (PCF) is a simple objective measure of cough and is the recommended measure in patients with NMD. Critical peak cough flow values are used to evaluate cough, these include PCF less than 160 L/min to indicate an ineffective cough, PCF between 161- 270 to indicate an impaired cough and PCF greater than 270 L/min to indicate an effective cough. Mechanical insufflator- exsufflator (MIE) devices more commonly known as 'cough assist' devices have an inbuilt measure of PCF however they aren't currently recommended for use to due to limited information available regarding their accuracy. This will be a single centre prospective observational study. Once patients have consented to participate in the study, they will be visited once on the unit during their admission by the researcher with the visit lasting approximately an hour.
During the visit they will receive their usual care MIE with a pneumotachograph fitted into the circuit. The primary outcome is the agreement of MIE assisted PCF measures between the MIE device and pneumotachograph. Before and after the intervention the patient will be asked to rate the presence of mucous in their lungs using a visual analogue scale.
The following data will be recorded
300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.
This study's enrollment of 10 is below the median of 77 across 121 observational studies indexed under Neuromuscular Diseases.
Browse Neuromuscular Diseases studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with neuromuscular related respiratory failure and receiving MIE as part of their usual care
Exclusion Criteria:
This device augments a cough by applying a positive pressure via the upper airway or tracheostomy to increase lung volume to maximal inspiratory capacity, followed by a rapid and quick change to negative pressure to increase expiratory flow and simulate normal cough mechanism
Agreement of Peak Cough Flow between MIE and pneumotachograph.
Peak Cough Flow measure the peak flow of expired air during the exsufflation phase of cough or MIE assisted cough
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Visual Analogue Scale
Patients will be asked regarding their perceived presence of chest secretions pre and post and post intervention using the visual analogue scale. The scale ranges from 0 to 10 with 10 being the highest perceived score.
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Treatment effect size of PCF during usual MIE care
Will compared baseline voluntary PCF to MIE assisted PCF
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE Pressure and PCF
Exploratory analysis of the correlation between MIE Pressure with PCF and cough function will be performed using chi square, correlation and logistic regression as appropriate.
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE inspiratory Volume and PCF
Exploratory analysis of the correlation between MIE inspiratory volume with PCF and cough function will be performed using chi square, correlation and logistic regression as appropriate.
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Intra-subject variance of repeated PCF measures
For patient receiving more than one cycle of MIE during their usual care, the repeated PCF measures taken by MIE and Pneumotachograph and variance of measures evaluated
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Plan to share: Undecided
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust